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  1. FDA Basics for Industry

Radiation-Emitting Products FAQs

Overview of Radiation-Emitting Products

How can I find out if my product is regulated by CDRH?

What gives FDA the authority to regulate manufacturers of radiation-emitting electronic products?

What products are regulated as electronic products that emit radiation?

Performance Standards

How do I know if an FDA performance standard applies to my product?

Importation of Electronic Products

What must I do to import radiation-emitting products into the US?

Getting More Information

Is it acceptable to contact CDRH to get guidance on the meaning of specific requirements of a performance standard or applicable regulation?

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